The Board proposes the rule amendment to update the rule regarding coursework for administration of vaccines and to provide language concerning coursework and training for pharmacy technicians in administration of vaccines.....

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-26.1031Vaccine Certification Program

PURPOSE AND EFFECT: The Board proposes the rule amendment to update the rule regarding coursework for administration of vaccines and to provide language concerning coursework and training for pharmacy technicians in administration of vaccines.

SUMMARY: The rule amendment updates the rule regarding coursework for administration of vaccines and provides instruction concerning coursework and training for pharmacy technicians in the administration of vaccines.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Committee meetings and Board meetings, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 465.005 FS.

LAW IMPLEMENTED: 465.189 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Jessica Sapp, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254; [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-26.1031 Vaccine Certification Program.

(1) No change.

(2) The Board shall approve for initial certification of pharmacist and pharmacy intern administration of vaccines, programs of study not less than 20 hours that include coursework covering all of the following:

(a) through (l) No change.

(m) The immunization and vaccine guidelines in the February 11, 2021, Adult Immunization Schedule by the United States Centers for Disease Control and Prevention, entitled “Recommended Adult Immunization Schedule – United States – 2021,” which is hereby incorporated by reference. The Schedule may be obtained from http://www.flrules.org/Gateway/reference.asp?No=Ref-13874, and the Board office at the address in subsection (1);

(n) The immunizations or vaccines recommended by the United States Centers for Disease Control and Prevention for international travel as of April 30, 2021, which may be found in the CDC Health Information for International Travel (2020 Edition), which is incorporated herein by reference. The material incorporated is copyrighted material that is available for public inspection and examination, but may not be copied, at the Department of State, Administrative Code and Register Section, Room 701, The Capitol, Tallahassee, Florida 32399-0250, and at the Board office at the address in subsection (1);

(o) through (q) No change.

Successful completion of the certification program must include a successful demonstration of competency in the administration technique and a cognitive examination.

(3) The Board shall approve for initial certification of registered pharmacy technician administration of vaccines, programs of study, accredited by the Accreditation Council for Pharmacy Education (ACPE), not less than 6 hours that include coursework covering all the following:

(a) Technique for preparing and administering immunizations in a safe and effective manner

(b) Administration routes

(c) Recognizing and responding to allergic vaccine reaction and other emergency situations

(d) Needle selection based on vaccines and patient size and age

(e) Documentation procedures

(g) A real time competency validation through the observation and return demonstration of a complete successful administration of an intramuscular and subcutaneous injection to a human being which shall include distraction techniques during the administration and universal precautions as they pertain to blood borne pathogens.

Rulemaking Authority 465.005 FS. Law Implemented 465.189 FS. History–New 3-20-08, Amended 8-30-10, 7-29-13, 5-29-16, 11-18-21,      .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Pharmacy

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: May 16, 2022

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: August 15, 2022